BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2861104 · Received December 4, 2012

    Report

    Report Number
    1627487-2012-12620
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2012-12708. THE PT REPORTED HAVING STIMULATION COVERAGE BUT IT IS NOT PROVIDING ADEQUATE PAIN RELIEF. THE PT ALSO REPORTS A NEW PAIN UNDER THE IPG POCKET SITE WHETHER STIMULATION IS ON OR OFF. REPORTEDLY THE PT HAS LOST WEIGHT MAKING THE IPG MORE SUPERFICIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 171869

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| SCS EXT: MODEL 3386